NDC 63323-416

Cisatracurium

Cisatracurium Besylate

Cisatracurium is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Cisatracurium Besylate.

• Product ID: 63323-416_0d662c1d-2eef-4e5f-8610-fe606716c810
• NDC: 63323-416
• Product Type: Human Prescription Drug
• Proprietary Name: Cisatracurium
• Generic Name: Cisatracurium Besylate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-02-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203182
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: CISATRACURIUM BESYLATE
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 63323-416-05

10 VIAL in 1 CARTON (63323-416-05) > 5 mL in 1 VIAL (63323-416-01)

• Marketing Start Date: 2015-02-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-416-05 [63323041605]

Cisatracurium INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA203182
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-02-26

Drug Details

Active Ingredients

Ingredient	Strength
CISATRACURIUM BESYLATE	2 mg/mL

OpenFDA Data

• SPL SET ID: f78a07e2-0d3b-4460-b29e-8c10c90afbda
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 80YS8O1MBS
• RxNorm Concept Unique ID - RxCUI:
  • 199212
  • 1730194
  • 199211

Pharmacological Class

• Neuromuscular Nondepolarizing Blockade [PE]
• Nondepolarizing Neuromuscular Blocker [EPC]

NDC Crossover Matching brand name "Cisatracurium" or generic name "Cisatracurium Besylate"

NDC	Brand Name	Generic Name
63323-418	Cisatracurium	Cisatracurium
63323-416	Cisatracurium	Cisatracurium
63323-417	Cisatracurium	Cisatracurium
0409-1098	Cisatracurium Besylate	CISATRACURIUM BESYLATE
0409-1103	Cisatracurium Besylate	CISATRACURIUM BESYLATE
0074-4378	Nimbex	Cisatracurium besylate
0074-4380	Nimbex	Cisatracurium besylate
0074-4382	Nimbex	Cisatracurium besylate